Fishbowl Manufacturing is a business automation and inventory management platform for small to mid-sized. It integrates with QuickBooks accounting.
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Fishbowl Manufacturing is a business automation and inventory management platform for small to mid-sized. It integrates with QuickBooks accounting.
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True ERP is an operations management suite available in both cloud-based and on-premise formats which caters to SMB enterprises like wholesalers, construction firms and retailers, along with others.
True ERP contains several different...
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True ERP is an operations management suite available in both cloud-based and on-premise formats which caters to SMB enterprises like wholesalers, construction firms and retailers, along with others.
True ERP contains several different...
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Mar-Kov CMS (Chemical Management System) was developed to meet the unique needs of process, batch, and formulation based manufacturers. By automating daily routine processes, companies are able to streamline their operations while...
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Chempax by Datacor is an integrated enterprise resource planning (ERP) and customer relationship management (CRM) application designed specifically for chemical process manufacturers and distributors. The solution can be scaled to...
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Chempax by Datacor is an integrated enterprise resource planning (ERP) and customer relationship management (CRM) application designed specifically for chemical process manufacturers and distributors. The solution can be scaled to...
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Epicor ERP is a fully integrated ERP solution with extensive functionality for accounting, inventory control, pre-production materials planning, and manufacturing execution (MES). The system is delivered either on-premise, hosted,...
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Epicor ERP is a fully integrated ERP solution with extensive functionality for accounting, inventory control, pre-production materials planning, and manufacturing execution (MES). The system is delivered either on-premise, hosted,...
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Priority is an on-premise and cloud-based enterprise resource planning (ERP) solution suitable for midsize to large businesses in many industry segments including manufacturing, apparel, electronics, food and beverage, industrial machinery...
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Priority is an on-premise and cloud-based enterprise resource planning (ERP) solution suitable for midsize to large businesses in many industry segments including manufacturing, apparel, electronics, food and beverage, industrial machinery...
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BatchMaster ERP is an integrated enterprise resource planning (ERP) solution for small and midsize process manufacturing companies. AS an OEM SAP solution, it performs a wide range of business management functions including, business...
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BatchMaster ERP is an integrated enterprise resource planning (ERP) solution for small and midsize process manufacturing companies. AS an OEM SAP solution, it performs a wide range of business management functions including, business...
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Microsoft Dynamics GP is a financial accounting system designed to meet the requirements of small to midsize businesses. Microsoft Dynamics GP was originally developed by North Dakota-based Great Plains Software and was acquired by...
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JD Edwards Financial Management is the accounting component of Oracle's JD Edwards EnterpriseOne product line. JD Edwards Financial Management can serve businesses of any size. The system is horizontal; it is designed to serve the...
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SAP Business One is an integrated enterprise resource planning (ERP) software suite designed primarily to serve small to midsize businesses. SAP Business One is used to address the needs of many industry verticals including manufacturing,...
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A solution for managing workforce, machines, and orders, ShopVue is a shop floor control solution that streamlines production. The system is designed to collect data for discrete manufacturers who are job-centric. The sysem provides...
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ProcessPro believes in one basic rule: as soon as business owners start to get more from their information, they will start to get more out of their business as well. It’s that simple. Intelligent Enterprise Resource Planning (ERP)...
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ProcessPro believes in one basic rule: as soon as business owners start to get more from their information, they will start to get more out of their business as well. It’s that simple. Intelligent Enterprise Resource Planning (ERP)...
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Ross ERP by Aptean is an enterprise resource planning (ERP) solution designed for the needs of process manufacturing companies in the food and beverage, chemicals, pharmaceutical and biotech industries. The solution is useful for...
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Ross ERP by Aptean is an enterprise resource planning (ERP) solution designed for the needs of process manufacturing companies in the food and beverage, chemicals, pharmaceutical and biotech industries. The solution is useful for...
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Oracle SCM Cloud offers a full suite of applications for companies to manage their supply chain, distribution, manufacturing, inventory management, and fleet.
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Oracle SCM Cloud offers a full suite of applications for companies to manage their supply chain, distribution, manufacturing, inventory management, and fleet.
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Infor CloudSuite Business is a comprehensive cloud-based ERP solution geared towards small and mid-sized businesses.
This integrated solution provides deep visibility into every business facet, from financials and human resources...
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Infor CloudSuite Business is a comprehensive cloud-based ERP solution geared towards small and mid-sized businesses.
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Infor Process Manufacturing Essentials Software is an integrated system designed to specially address the management and automation needs of process manufacturers.
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Infor Process Manufacturing Essentials Software is an integrated system designed to specially address the management and automation needs of process manufacturers.
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MRPEasy is a manufacturing software for small manufacturers. The software is a suite comprising production planning, CRM, procurement, supply chain management, and inventory control modules. The application features a drag-and-drop...
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S2K Enterprise Management Software by VAI is a fully integrated ERP system designed to manage mid-sized and enterprise businesses in the wholesale distribution, manufacturing and speciality retail industries, across many vertical markets...
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S2K Enterprise Management Software by VAI is a fully integrated ERP system designed to manage mid-sized and enterprise businesses in the wholesale distribution, manufacturing and speciality retail industries, across many vertical markets...
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SAP Business All-in-One is an integrated enterprise resource planning solution for midsize and large companies, serving clients across the North America. The solution offers construction accounting, customer management, and service...
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SAP Business All-in-One is an integrated enterprise resource planning solution for midsize and large companies, serving clients across the North America. The solution offers construction accounting, customer management, and service...
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Buyer's Guide

Pharmaceutical manufacturers must contend with the conflicting requirements for complying with regulations from up to a half dozen federal agencies—with the need to maintain security, particularly during the development and testing phases. And then they have to put out consistent, quality product at the end of the day. While large, multi-billion dollar firms dominate the headlines, there are still a large number of smaller firms that make either a single pharmaceutical, ingredients for other manufacturers or specialize in medications with expired patents.

What Is Pharmaceutical Manufacturing Software?

Three of the most critical features companies are looking for in their pharmaceutical manufacturers software are:

Inventory management: Since pharmaceutical ingredients and products are often controlled substances and must be secured, you can imagine the importance of a detailed inventory system for tracking these controlled substances. Substances used in the process also often have limited shelf lives. As such, they need to be rotated and used in a timely fashion.

Production management/quality assurance: Production management must include recipe scaling for different batch sizes. Batch tracking, again for both ingredients and products, is mandated as part of recall management.

Regulatory compliance: There’s a ton of regulatory compliance pharma manufacturers have to wade through. Not only must the shipping be documented, but disposal must be secure, documented and non-polluting. Even manufacturing start-up is regulated for some compounds. New and updated pharmaceutical manufacturing systems should support the FDA’s process analytical technology (PAT) initiative.

In addition to these three critical capabilities, most pharmaceutical management systems also offer some forms of fulfillment system that addresses both the security and shipping labeling aspects, both of which are stricter than general fulfillment systems.

Accounts receivable is standard except that the sums involved can be in the millions of dollars and for some products the customers must be positively identified. Payroll and personnel are again standard, as are general ledger and accounts payable.

If pharmaceutical manufacturing operations are part of a parent firm, they are likely to be using part of an organizational enterprise resource planning (ERP) system. Small and medium firms may use stand-alone accounting modules but are more likely to use manufacturing-specific systems. Most manufacturers use premises-based systems, but security is more of a driver than is cost.

Common Features of Pharmaceutical Manufacturing Software

Pharmaceutical manufacturers should examine the following functions while considering their unique requirements:

Formulation management and batch sizing

The system should include formulation management, including ingredient substitution and batch scaling. Advanced systems can size batches to quantities of ingredients in stock. The system should provide for formulations of different strengths.

Available to promise, capable to promise

Available to promise (ATP) and capable to promise (CTP) are measures of manufacturing capacity. The system should calculate the ATP and CTP for any stock item, accounting for ingredients on hand and any work in process.

Lot tracing and recall management

Each lot must be identified and tracked. The ingredients of each batch must be tied to their individual batch number as well.

Recall management

Recalls are initiated for two reasons. First, a problem in the process causes a product to become tainted or contaminated. Second, an ingredient is tainted or contaminated. In either case, the system needs to identify all of the affected batches and the customers that received those batches.

Hazard Analysis Critical Control Points (HACCP) compliance

The system should support reporting for Hazard Analysis Critical Control Points (HACCP), in accordance with HACCP Principle 7: “Establish record-keeping and documentation procedures.”

FDA compliance

The FDA is empowered to regulate standard and homeopathic pharmaceuticals; the standards for labeling are similar but have unique differences. The system should correctly label standard and homeopathic products as necessary.

Drug Enforcement Agency (DEA) compliance

If the pharmaceutical manufacturer makes products or uses ingredients regulated under the Controlled Substances Act, it is subject to oversight from the DEA. The system should document compliance with the act and have access to a current database of controlled substances, regulated chemicals and analogues.

Environmental Protection Agency (EPA) compliance

If the pharmaceutical manufacturer makes or uses products listed under the Toxic Substance Control Act, the substance may be regulated by the EPA. The system should maintain all compliant records as well as preparing a pre-manufacture notice before a new compound is created.

Quality assurance

The system should support quality assurance (QA) testing. The protocols should be documented and implemented through the system. The QA system should randomly identify samples for testing and compare test results against norms. Advanced systems will feature dashboards that will alertadministrators to problems with quality.

Process analytical technology support

The system should identify critical process parameters and define their affect on critical quality attributes as part of quality assurance testing.

Code of Federal Regulations 21 Part 11 compliance

Strictly speaking, no software package can be 21 CFR Part 11 compliant because the rule stipulates administrative and procedural controls as well as technical implementation for electronic and hybrid record keeping. However, it can support 21 CFR Part 11 by completely implementing the technical requirements.

Current Good Manufacturing Practice (cGMP) compliance

cGMP compliance is required for many regulatory agencies at the state and federal levels as well as for insurance purposes. The system should produce required compliance reports.

Yield variances

The system should track actual yield versus expected yield for each batch. The system should report excessive variance based on user-defined thresholds and indicate if variances are so large that regulating agencies should be notified.

Packing & drumming

The inventory system must be able to value and price items in different container sizes. It must also identify or generate suitable labels for containers.

Inventory storage planning

Some pharmaceuticals require a specific storage environment. The inventory system and receiving systems should notify workers about any special requirements.

Expiration tracking

Both pharmaceutical ingredients and pharmaceutical products can have limited shelf lives. The system needs to track expired and close-to-end-of-life inventory.

Shipping

Many pharmaceuticals have restrictions on shipping either via USPS or common carrier. In some cases, the contents of a package may not be listed on outside labeling. The system should identify any special requirements and produce appropriate shipping labels.

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